It is accepted in the biopharmaceutical field to use sterile individual sets comprising a sterile flexible bag having a peripheral wall defining a sterile internal space within which one or more fluidic-type functional member(s) is arranged, such as containers, tubes, or ports, which are part of more or less complex sets that can comprise a plurality of containers, tubes, and operative means, possibly associated with each other.
By convention, “biopharmaceutical product” is understood here to mean a fluid originating from biotechnology—culture media, cell cultures, buffer solutions, artificial nutrition liquids—or a pharmaceutical fluid or more generally a fluid intended for use in the medical field.
In the technical field of biopharmaceutical production, there are various known prior art solutions to the challenges of orderly and organized retention of fluidic-type functional members within the sterile internal space of a flexible bag, to make it faster and easier to grasp and use these functional members during the manufacture of biopharmaceutical products.
In particular, a sterile individual set according to the preamble of claim 1 is known to the skilled person by the example given in document FR-A1-2,956,092. That document describes a sterile individual set comprising a bag provided with a peripheral wall defining a sterile internal space within which a functional member is arranged, corresponding for example to a distribution means. This distribution means has a plurality of communication conduits also arranged within the sterile internal space of the bag and provided to ensure the sterile fluid transfer of fluid components during the manufacture of a biopharmaceutical product. To ensure proper organization and facilitate the manipulation of these communication conduits within the sterile internal space, the sterile individual set described by FR-A1-2,956,092 comprises structural association means that group a portion of the communication conduits together to form a communication conduit bundle. More particularly, these structural association means are formed by thin straps that are looped to constitute ties which allow defining a communication conduit bundle.
However, such an embodiment has several disadvantages. In particular, due to the composition of the communication conduits and the peripheral wall of the flexible bag, friction forces are generated between the communication conduits and the peripheral wall during the insertion or removal of the bundle of communication conduits into or from the sterile internal space of the flexible bag. These frictional forces have the effect of interfering with operator manipulations of the bundle of communication conduits and therefore lengthen the phases of inserting or removing the functional member into or from the flexible bag. In addition, these frictional forces generate stresses on the peripheral wall of the flexible bag which may damage the bag, thus increasing the risk of a loss of integrity of the sterile internal space of the flexible bag.
One solution for overcoming these adhesion issues consists of a surface treatment to reduce the frictional forces between the outer face of the communication conduits and the peripheral wall. The publication “Traitement plasma et caractérisations de surface des silicones” (Plasma treatment and surface characterizations of silicones) by J. Viard, available on the Internet, concerns creating a fluorine plasma in order to deposit a thin fluorine layer on the outer surface of silicone tubes and thus reducing their adhesion.
However, such a solution changes the composition of the communication tubes. This creates qualification issues in the manufacture of biopharmaceutical products, and requires applying a surface treatment which significantly complicates their manufacture and therefore leads to procurement issues and additional production costs.
In a technical field that is completely different from biopharmaceutical production, such as the handling of electrical cables, prior art structural association means are known that are formed by flexible spiral sheaths. As an illustrative example, an embodiment of such flexible spiral sheaths is commercially available under the brand Pro-Tec-To Wrap® which aims to provide protection for bundled electrical cables that is both flexible and resistant.
However, using such spiral sheaths to form a bundle of fluid communication conduits in the technical field of biopharmaceutical production has never been mentioned, nor has employing such flexible spiral sheaths to reduce—or even eliminate—the adhesion of such a bundle of communication conduits to a peripheral wall of a flexible bag.